ted johnson, md, mph · definitions- ahrq focus group • terminology agreement around:...
TRANSCRIPT
Role for Multicomponent Interventions
Ted Johnson, MD, MPH Birmingham/Atlanta VA GRECC
Emory General Medicine and Geriatrics Emory Family and Preventive Medicine Rollins Public Health/ Emory Urology
Disclosures
• Salary : VA, Emory University, Emory Clinic, Grady Health • Royalty : Author royalty, Up-To-Date, topic card on nocturia • Funding: VA; NIDILRR • Stock : None • Speakers Bureau : None • Consultant (2 yrs): Astellas (clinical trial design), Vantia (QoL
instrument development), Medtronic (non-drug tx for UI) • Other : Speaker at
– AUA Foundation Meeting: UI in Primary Care – American College of Physicians meeting through an un-restricted
educational grant from Astellas
Outline
1. Significance 2. State-of-the-Art Knowledge 3. Knowledge Gaps and 4. Research Opportunities
Multicomponent Interventions: Standardized Framework
• Multicomponent Intervention: not a MESH term1
• Clinical Trial (Intervention Study) are both MESH terms: . . . in which participants are assigned to receive one or more interventions
• Other modifying terms: multifaceted; complex; behavioral plus drug
1https://www.nlm.nih.gov/cgi/mesh/2016/MB_cgi on September 16, 2016
Definitions- AHRQ Focus Group
• Terminology agreement around: Complex, multicomponent, health system interventional trials
• The word multicomponent, by contrast, was generally recommended by the interviewees1 – “I think, that the value about distinguishing multicomponent
interventions are because there are questions about the interaction of the components, which components are critical and variation across the individual components, across different studies. So thinking about them and how to collect information is useful.”
1 AHRQ Review, 2014: Systematic Reviews of Complex Multicomponent Health Care Interventions [Internet]. Guise JM, Chang C, Viswanathan M, et al. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Mar.
Definitions- AHRQ Focus Group
• Terminology agreement around: multicomponent • The word multicomponent, by contrast, was generally
recommended by the interviewees1 – Interaction of the components – Which components are critical – Variation across the individual components – How that differs across studies
1 AHRQ Review, 2014: Systematic Reviews of Complex Multicomponent Health Care Interventions [Internet]. Guise JM, Chang C, Viswanathan M, et al. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Mar.
McConnell, NEJM 2003, 349: 2347
Lower progression better
same
best
MTOPS (α-blocker + 5-αRI) for BPH sx’s: a multicomponent intervention?
Must the interventions come from different domains? 3 or more? Include behavioral?
State-of-the-Art Knowledge
• Multicomponent interventions common – Smoking cessation, asthma management, reducing
buzzed-driving, weight loss, HIV elimination
• Conditions with multiple, interacting risk factors – Geriatric conditions specifically- falls, delirium,
functional dependence, urinary incontinence1, insomnia2
• Multicomponent interventions for achieving multiple outcomes
1Burgio et al. JAGS 2011, 2Tyagi JAGS 2014
State of Art Knowledge: Role for Multicomponent Interventions
• Conditions with multiple, interacting risk factors • Where single intervention less effective/ineffective:
delirium • No clear evidence on cholinesterase inhibitors, antipsychotic
medication or melatonin to reduce incidence • Strong evidence supporting multi-component interventions to
prevent delirium in hospitalised patients1
• Targeting multiple outcomes2
1Siddiqi et al. Dementia and Cognitive Improvement Group. 2016 2Wenger et al. Primary Care intervention for Falls, UI, Dementia. 2009
State of the Art Knowledge: Multiple Interacting Risk Factors
In Inouye, Studenski, Tinetti, Kuchel. J Amer Geriatr Soc 2007
Modified from Decker, Sausville. Ann NY Acad Sci 2005
Geriatric Syndromes: Clinical, Research and Policy Implications of a Core
Geriatric Concept
Hypertension Congestive Heart Failure Symptomatic Congestive Heart Failure with Nocturia
Geriatric Syndromes: Clinical, Research and Policy Implications of a Core
Geriatric Concept
Weiss, Blaivas, et al. BJU Int. 2013
Geriatric Syndromes: Clinical, Research and Policy Implications of a Core
Geriatric Concept
Nocturia
Nocturnal Polyuria
Low Bladder Capacity
Global polyuria
Geriatric Syndromes: Clinical, Research and Policy Implications of a Core
Geriatric Concept
Vaughan, Eisenstein, Bliwise, Endeshaw, Nagamia, Wolf, Johnson. Int J Clinical Practice 2012
Nocturia
Interaction between voiding and sleep bother from nocturia
4+ episodes
nocturia (N=21)
2-3 episodes
nocturia (N=34)
0-1 episodes
nocturia (N=0)
LOW bother
(N=13)
HIGH bother
(N=11)
Vaughan, Eisenstein, Bliwise, Endeshaw, Nagamia, Wolf, Johnson. Int J Clinical Practice 2012
Sleep Characteristic
LOW Bother (±s.d.)
HIGH bother (±s.d.) P-value
Return to sleep (min)
16.1 (± 11.4) 28.8 (± 13.9) 0.03
Fatigue- Morning
5.7 (±0.9) 4.7 (±0.7) 0.01
Higher # better
SOTA: Where Single Interventions Less Successful
Experimental Designs1
• Test multicomponent interventions for multifactorial health conditions
• Identification and selection of modifiable risk factors related to the outcome of interest – Known risks targeted risk factors (foot problems2,
palmomental reflex2, sedative use2,3, polypharmacy3), hearing loss
• Selection of intervention components to reduce the deleterious effects of the modifiable risk factors
1Allore et al. Clinical Trials 2005; 2Tinetti NEJM 1988, 3Tinetti NEJM 1994
Elements of Multicomponent Trials
Allore, Tinetti, Gill, Peduzzi. Experimental designs for multicomponent interventions among persons with multifactorial geriatric syndromes. Clinical Trials. 2005
Elements of Multicomponent Trials
Allore, Tinetti, Gill, Peduzzi. Experimental designs for multicomponent interventions among persons with multifactorial geriatric syndromes. Clinical Trials. 2005
• Outcome • Risk factor prevalence & correlation • # components and assignment • Measurement of risk factors at follow-up • Blinded allocation and assessment • Sample size and power • Estimated component effects
Targeting of Multiple Outcomes with Multiple Interventions
1 Leipzig R M et al. Ann Intern Med 2010;153:809-814;
Proposed USPSTF Framework for multiple outcomes1
Knowledge Gaps
• Standardized definition, MESH term • Methodological concerns about meta-analyses of
multicomponent trials • Which elements belong? • How multicomponent strategies fit together
(macro)- National strategy for HIV; Alzheimer’s disease
Combined Multicomponent: Vision; Goals; Indicators
Goals of the National HIV Strategy 1. Reduce New Infections 2. Increase Access to Care and Improve Health
Outcomes for People Living with HIV 3. Reduce HIV-Related Health Disparities and
Health Inequities 4. Achieve a More Coordinated National
Response to the HIV Epidemic
https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf
Goals Steps: Multicomponent Interventions
https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf
Meta-analysis Consideration- AHRQ Framework (9 points)
• Holistic- look at effectiveness of whole bundle • Intervention features or factors- group by components
(exercise + PT); active components (home monitoring); theory; context – PICOTS framework (Patient population, Intervention, Comparator,
Outcomes, Timing, Setting); they focus on ways of categorizing the intervention or its components, the setting, or both.
• Factors influencing success or behavior- realistic (evidence informed care), mechanism of action, configurational (needed, but not sufficient)
AHRQ Review, 2014: Systematic Reviews of Complex Multicomponent Health Care Interventions [Internet]. Guise JM, Chang C, Viswanathan M, et al. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Mar.
Choosing Multicomponent
Elements • Multiphase optimization strategy
(MOST) • Sequential experimentation with
results feeding forward • Calculated risks for speed • Move intervention science fastest,
even if slower progress in the short run
• Standardized RCT only following optimization
Collins, L. M., et al. (2011). Annals of Behavioral Medicine, 41, 208-226.
Research Opportunities
• MESH heading, standards • Look at AlzDz and HIV models for
overarching strategy for progress as potential model
• Collaborative efforts with behavioral scientists, implementation science
• Packaging UI/LUTS outcome measures to be integrated into other trials – SPRINT, LIFE, SOF
Future Research Framework1
1Allore et al. Clinical Trials 2005
Future Research Framework1
1Allore et al. Clinical Trials 2005
• Terminology, reporting standards • Design issues • Ideal # risk factors, correlation, grouping • How many components, assignment • Sample size, comparison group • Effect of individual components, bundle
of components
Recap: Multicomponent Interventions
1. Significance 2. State-of-the-Art Knowledge 3. Knowledge Gaps and 4. Research Opportunities